Kinetica provides a broad collection of tools to meet the needs of scientists engaged in various disciplines, from bioanalytical laboratory to clinical trials. Kinetica is also the analytical engine within Thermo’s Enterprise Pharmacology Series, a powerful pharmacokinetic-pharmacodynamic data management, analysis, simulation, database and reporting solution.

With an intuitive point-and-click graphical interface, Kinetica facilitates data analysis and reporting in a flexible, easy-to-learn environment. A unique non-compartmental assistant technology and a multitude of different standard and advanced PK, PD and PK-PD models offer the best in high-throughput data analysis. Import your data or create datasets, select and tailor your computational methodologies, view your data with dynamic graphical tools, view individual and study results in an organized fashion, export your result through the seamless interface to other software.

Designed as a template-driven system, Kinetica allows you to create predefined templates and analysis settings. The template format allows high-throughput analysis and customized automation to standardize analyses based on company SOP and guidelines; the same format can be applied to any other studies thereby offering standardization across your organization. The advantages for your company are high consistency between analyses and between users, time savings in not having to put efforts in validating each user’s analysis, and version control between analyses of the same study.

With the seamless interface with Thermo’s Watson bioanalytical LIMS, Kinetica brings you fast and rapid analysis and report so you do not need to spend time moving data from software to another. Built as a single solution for non-compartmental, standard compartmental, population pharmacokinetic analyses, bioequivalence, graphing and reporting, Kinetica again saves you time transferring and formatting data.

Non-compartmental Analysis (NCA)
The innovative NCA assistant allows rapid view of the analysis via a graphical point-and-click interface. Kinetica recognizes flagged data for below limit of quantification, outlier, error and missing to allow user to specify the handling of flagged data during the analysis without sacrificing the data themselves.

Unit Management
With a powerful unit management tool, user can specify the output pharmacokinetic parameter units as well as input time and concentration units from an extensive list of measurement units. Versatile unit conversions are built into the tool for molar conversion.

Data Exchange and Storage
Ever have the experience of not finding your analyses from years back when drug filing is coming close? Kinetica gives you the simple single file storage so you no longer need to save your analysis into many separate files. All data and analysis information are stored in a single file, including method information, algorithms, graphs and reporting set-up.

The Import Assistant provides an easy import of row- and column-based data from Microsoft Excel, ASCII files and direct ODBC-compliant data sources. It also includes support for direct Oracle database import from the Watson bioanalytical LIMS system. In addition, your data and analysis results can be exported to ASCII, Microsoft Word or Excel.

The Table Assistant comes with predefined table structures for all your reporting needs. Table structure templates include preclinical, clinical, toxicokinetic, sparse study designs. The tool allows you to preset the number of significant digits or decimal points for your data and results.

Kinetica for Population PK/PD Analysis
Even if you have NONMEM, Kinetica population analysis will compliment your NONMEM experience by providing accurate initial estimates so that your NONMEM analysis runs smoothly. Kinetica’s robust population analysis module gives you fast and accurate results. The system includes a powerful multi-dimensional search option to identify relationships between the model parameters and available covariable.

Kinetica incorporates the EM algorithm that was originally in P-Pharm. The population estimation algorithm in Kinetica is an iterative process that computes the maximum likelihood estimates. It also allows the user to incorporate covariable model and to check for the decrease in interindividual variability of the parameter estimates after taking the covariable model into account.

Kinetica also allows the user to perform both external and internal validation of the population model. The user can apply the existing population model to a new dataset from another study (external validation) or the user can split the data into either the test set or the validation data set (internal validation). Kinetica uses two methods to validate population models, namely (1) Prediction errors on concentration method (or concentration method) and (2) validation through parameter method (or parameter method). The concentration method uses the parameter values from the test dataset to predict the concentration for individuals in the validation dataset group. In the parameter method, model parameters are predicted from the validation data set with or without covariates; bias and precision are calculated for the predictions.

Data Analysis
Kinetica includes more than 60 different validated templates, including non-compartmental, PK, PD and PK-PD fitting for standard compartmental and population analyses, absorption, convolution, deconvolution, renal, protein binding, enzyme kinetics, transdermal, in-vivo and in-vitro correlation, and in-vitro dissolution. It comes with an extensive library of data analysis methods.

Testing Agent
The Automated Test Agent performs a complete comparison of the calculations of Kinetica as it is installed on your system with reference analysis outputs that were generated in Thermo’s QA environment. Test Agent would help with IQ and perhaps a part of OQ, as it is a basic check that the software is installed and calculating correctly in your environment. The second stage involves testing the features of the software to ensure they are performing as intended.